The FDA has approved the country’s first biosimilar for adults with cancer. Bevacizumab-awwb, which will be marketed as Mvasi, has been approved to treat the same types of cancers as its reference product, bevacizumab, which is sold as Avastin.

The drug is a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF). By blocking VEGF’s interaction with its receptors, bevacizumab-awwb prevents the development of new blood vessels that solid tumors need to thrive. Bevacizumab-awwb and bevacizumab are from different manufacturers that use their own unique cell line and proprietary processes. Differences between the 2 drugs aren’t clinically meaningful in terms of safety, purity, and potency.

FDA已经批准了该国首个用于成人癌症的生物仿制药。贝伐单抗-awwb（将以Mvasi的形式出售）已获准与其参考产品贝伐单抗（以阿瓦斯汀出售）治疗相同类型的癌症。

该药物是重组免疫球蛋白G1单克隆抗体，可与血管内皮生长因子（VEGF）结合。贝伐单抗-awwb通过阻断VEGF与受体的相互作用，阻止了实体瘤需要壮成长的新血管的发展。贝伐单抗-awwb和贝伐单抗来自不同的制造商，它们使用自己的独特细胞系和专有工艺。在安全性，纯度和效力方面，两种药物之间的差异在临床上没有意义。